Lexology January 3, 2024
On December 13, 2023, the US Department of Health and Human Services (HHS), via the Office of the National Coordinator for Health Information Technology (ONC), finalized the Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing (HTI-1) rule. The final rule builds on the proposed HTI-1 rule released in April 2023, which attracted significant public comment.
Along with new interoperability and enhanced information blocking requirements, the HTI-1 final rule establishes groundbreaking transparency requirements for artificial intelligence (AI) and other predictive algorithms in certified health IT. The algorithmic transparency requirements specify the provision of baseline algorithm information, designed to allow clinical users to evaluate algorithm fairness, appropriateness, validity, effectiveness and safety (FAVES). ONC is eager to adopt...
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